Clinical Evaluation of Air Handling in Baby fx Oxygenator With Integrated Arterial Filter Versus Baby rx Oxygenator With Non Integrated Arterial Line Filter

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01296685
First received: February 14, 2011
Last updated: May 31, 2011
Last verified: February 2011

February 14, 2011
May 31, 2011
March 2011
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Complete list of historical versions of study NCT01296685 on ClinicalTrials.gov Archive Site
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Clinical Evaluation of Air Handling in Baby fx Oxygenator With Integrated Arterial Filter Versus Baby rx Oxygenator With Non Integrated Arterial Line Filter
Clinical Evaluation of Air Handling in Baby fx Oxygenator With Integrated Arterial Filter Versus Baby rx Oxygenator With Non Integrated Arterial Line Filter

The goal of the study is the evaluation of the air handling of a "new" type of oxygenator versus the standard model. The new type has an integrated arterial filter. The standard model has a non integrated arterial line filter. If the air handling is as effective/ better than in the standard model this can lead to reduction of cardiopulmonary bypass circuits with their initiation of systemic inflammatory response and improve cardiopulmonary bypass safety.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

All children with body surface area between 0.25 and 0.5 m² who need cardiac surgery with cardiopulmonary bypass. Urgent and norwood procedures are excluded.

Cardiovascular Surgical Procedure
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  • oxygenator with arterial filter
  • arterial filter
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
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Inclusion Criteria:

  • All children with body surface area between 0.25 and 0.5 m² who need cardiac surgery with cardiopulmonary bypass.

Exclusion Criteria:

  • Urgent and norwood procedures.
Both
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No
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NCT01296685
S 52937
Yes
Dr. Al Tmimmi, University Hospitals Leuven
Universitaire Ziekenhuizen Leuven
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Principal Investigator: Layth Al Tmimi, Dr. University Hospitals Leuven
Universitaire Ziekenhuizen Leuven
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP